Condition category
Digestive System
Date applied
02/09/2019
Date assigned
09/09/2019
Last edited
09/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Inflammatory Bowel Disease (IBD) affects 300,000 people in the UK , causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea, and pain. In remission, many people with IBD live with fatigue, chronic abdominal pain, and bowel urgency/incontinence. There is no current cure for IBD, which usually starts in childhood or as a young adult. Most previous IBD research has focused on controlling inflammation. However, many people report continuing IBD-related fatigue (41%), abdominal pain (62%) and difficulty with continence (up to 75%) even when IBD is in remission. These symptoms limit peoples’ quality of life and ability to work and socialise. Patients feel that these symptoms are not taken seriously by health professionals and report that little help is given. However, the James Lind Alliance IBD research priority-setting consensus put fatigue, pain, and continence in the top 10 issues that IBD patients and clinicians want to be addressed by research.

The current application is stage four of IBD-BOOST, a National Institute of Health Research (NIHR) Programme Grant for Applied Research (PGfAR) funded programme. The overall aim of the Programme Grant is to improve the quality of life of people with IBD by reducing the burden of IBD-related fatigue, abdominal pain, and urgency/incontinence. The current application is for the final part of the project, a 2-arm randomised controlled trial (RCT) of a facilitator supported online intervention for people who have expressed a desire for intervention for fatigue, pain and/or urgency/incontinence, compared to care as usual.

Who can participate?
Patients 18 years old or over with a diagnosis of IBD, living in England, Scotland or Wales, and have participated in Stage 2 of the programme (IBD-BOOST) survey

What does the study involve?
This trial is testing whether an online self-management programme can improve symptoms and quality of life. Participants who consent to take part will complete an online questionnaire. An automated computer system will then put you into participants into one of two groups by chance (randomly):
- One group will receive a password to access an online self-management programme. It has 11 sessions, depending on the participant’s symptoms and can be completed over a few weeks or up to 6 months. The sessions can be done at any time, with some exercises in between, and should take a total of 1-2 hours per week. Participants will also have a professional facilitator who can give the participant online or telephone support.
- The other group will not have access to the online programme until 12 months later.
We will ask both groups to complete the questionnaires again 6 and 12 months later and you will receive £5 each time. 12 months after taking part, BOTH groups will have open access to the website but without facilitator support.

What are the possible benefits and risks of participating?
Benefits: For participants who haven't taken part in the IBD-BOOST Optimise study (Stage 3 of the IBD-BOOST programme), the faecal calprotectin stool sample results combined with the participant's checklist results may raise medical issues that the healthcare team can potentially help manage via the IBD algorithm (step by step guide) designed for the study. Participants could potentially then benefit from symptom (fatigue, pain and urgency/incontinence) relief. PPI indicated that people want to be reassured that "nothing has been missed" when they experience these symptoms. Participants who are randomised to the online self-management programme of the study, may find the programme beneficial as the aim is to address symptoms such as faecal urgency/incontinence, pain and fatigue utilising cognitive behavioural therapy components. Participants who have been randomised to the control arm (care as usual) group, will be offered access to the online intervention (but no facilitator support) at 12 months so that they have the potential benefit of the online self-management platform in future.
Risks: This is a low-risk study, although there is potential for participants to become distressed when thinking about their symptoms. The online intervention site will include a link/website address to CCUK who provide support via their helpline, and contact details are included in the Participant Information Leaflet. The outcome measures include questions on anxiety and depression. At the end of the questionnaire, there are helplines listed that can offer support and there is a protocol risk assessment. We recognise the potential burden on participants of these multiple outcome measures (Just under 150 questions). However, as we are assessing multiple symptoms and are keen to include potentially explanatory variables, we feel that these are necessary. We will send an unconditional £5 incentive to participants for both the 6 and 12 months follow-up. For participants who did not take part in the previous stage of the study (Stage 3 of the IBD-BOOST programme, the IBD-BOOST Optimise study), they may feel burdensome to send a faecal/stool sample for the calprotectin test, however this will be balanced by the benefit of knowledge regarding whether inflammation has been detected in a participant's sample, indicating active disease (flare). Patients with IBD are routinely asked to complete this test at many of their routine NHS clinic visits so this will not be a novel test.

Where is the study run from?
Trial study centres:
1. Northwick Park Hospital, UK
2. Salford Royal Hospital, UK
Trial run from:
1. King’s College London, UK
2. London North West University Healthcare NHS Trust, UK

When is the study starting and how long is it expected to run for?
October 2019 to June 2021.

Who is funding the study?
National Institute of Health Research (NIHR) Programme Grant for Applied Research (PGfAR), UK

Who is the main contact?
1. Prof. Christine Norton,
christine.norton@kcl.ac.uk
2. Mr Jonathan Syred,
jonathan.syred@kcl.ac.uk

Trial website

http://www.ibd-boost.ac.uk

Contact information

Type

Scientific

Primary contact

Prof Christine Norton

ORCID ID

http://orcid.org/0000-0003-2259-0948

Contact details

Florence Nightingale Faculty of Nursing
Midwifery and Palliative Care
King’s College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
+4420 7848 3864
christine.norton@kcl.ac.uk

Type

Public

Additional contact

Mr Jonathan Syred

ORCID ID

http://orcid.org/0000-0002-4479-1604

Contact details

Florence Nightingale Faculty of Nursing
Midwifery and Palliative Care
King’s College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
+4420 7848 3318
jonathan.syred@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RP-PG-0216-20001

Study information

Scientific title

A Randomised Controlled Trial of supported online self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial.

Acronym

IBD-BOOST

Study hypothesis

A facilitator-supported, online, tailored self-management programme for fatigue, pain and faecal urgency/ incontinence in people with IBD will result in better quality of life compared to care as usual at six months after randomisation.

Ethics approval

Approved 12/07/2019, London - Surrey Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44207 104 8310; NRESCommittee.SECoast-Surrey@nhs.net), ref: 19/LO/0750, IRAS ID: 258725

Study design

A pragmatic multi-centre two-arm parallel-group superiority randomised controlled trial with an internal pilot

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Inflammatory Bowel Disease (IBD)

Intervention

A pragmatic multi-centre two-arm, parallel group superiority RCT, with an internal pilot, of facilitator-supported online self-management versus care as usual to manage symptoms of fatigue, pain, and faecal urgency/incontinence in IBD. One baseline assessment and two assessments at 6 and 12 months after randomisation. Primary outcome: IBD quality of life at 6 months.

This trial will compare a web-based programme, known as 'BOOST', for self-management of pain, fatigue and urgency/incontinence symptoms of IBD ('BOOST' is based on the principles of cognitive behavioural therapy with telephone and online messaging support) to standard care.

The content has been developed by health psychologists to be interactive and tailored to patients’ needs. BOOST includes 11 online sessions which can be viewed on computer, smart phone or tablet.). Sessions 1-7, are core transdiagnostic sessions to be completed by participants experiencing fatigue, pain and faecal urgency/incontinence. Based on a Cognitive Behavioural model of IBD symptoms, the core sessions cover topics around: understanding IBD symptoms, balancing activity and exercise, sleep hygiene, changing negative thoughts, coping with stress and emotions, and making the most of social support. Sessions 8-11 are symptom-specific sessions to be completed by participants experiencing or with a specific interest in fatigue, pain and faecal urgency/incontinence, respectively. The symptom specific sessions provide participants with more in-depth psychoeducation on the interaction between medical and psychosocial factors contributing to the severity and impact of IBD symptoms, together with practical tips and exercises on how to better manage them.

Participants will be able to log into BOOST via a computer, tablet or smartphone, according to their preference, and complete approximately one session per week. Each session takes 30-60 minutes to complete. Participants will be able to complete the sessions at a time and place that is convenient to them and to pace themselves in a way that suits them and their lifestyle. In between sessions, participants will be asked to complete tasks which will help them to practice the skills acquired during the intervention sessions. Throughout the intervention, the participants will be supported via online messages by an assigned healthcare professional, who will act as their facilitator. The facilitator will have access to information on how participants are using the intervention (sessions and task completed) and will monitor and help to promote participants’ engagement with the intervention, together with supporting participants work towards achievement of their intervention goals.

Participants randomized to the intervention will have access to care as usual plus the online tailored self-management programme for six months, plus one individual telephone or Skype support session (for up to 30 minutes, training and a paper copy of the content will be provided for the facilitator), plus access to online messaging with their facilitator via the BOOST platform for the first three months after recruitment.

Participants randomised to the control have access to all usual care.

Participants in the intervention arm have access to the online self-management programme for six months, plus access to online messaging with their facilitator via the website platform for the first 3 months after recruitment.

Both the intervention and control group are followed up at 6 and 12 months,

Participants who consent, are eligible and return the baseline questionnaire will be randomised by the central research team using an online randomisation system developed for the study by the PCTU. The central team will then inform the participant which group they are in. Stratified central web-based randomisation to 2 groups. Stratified by:
- Diagnosis (Crohn’s disease vs. other IBD)
- Whether or not participated in WP2c study (OPTIMISE: medical symptom optimisation)
Allocation will be concealed until consent and baseline measurements completed

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief at six months after randomisation.

Secondary outcome measures

1. UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) at 12 months
2. Rating of satisfaction with results of BOOST programme (simple 0-100 visual analogue scale) at 6 and 12 months only
3. Global rating of symptom relief at 12 months
4. Numerical (0-10) pain rating scale at baseline, 6 and 12 months after randomisation
5. Vaizey (faecal) incontinence score, reflecting patients’ perceptions of severity at baseline, 6 and 12 months after randomisation
6. IBD-Fatigue score at baseline, 6 and 12 months after randomisation
7. IBD-Control score; 8-item self-reported score to measure disease control from the patient's perspective at baseline, 6 and 12 months after randomisation
8. EQ-5D-5L general health-related quality of life at baseline and 6 and 12 months after randomisation

Overall trial start date

01/11/2017

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of IBD (self-reported as having been medically diagnosed with IBD including patients with an ileo-anal pouch or stoma)
2. 18 years old or over
3. Living in England, Scotland or Wales
4. Have participated in Stage 2 of the programme (IBD-BOOST survey) and have self-scored one or more symptoms of fatigue, pain or urgency/incontinence as having an impact on their life of 5 or more on a 0-10 scale when completing Stage 2 (IBD-BOOST survey) or Stage 3 (medical symptom optimisation) (whichever is the more recent)
5. No “red flags”– see below
6. Access to the online intervention via a computer or mobile device

Screening for 'red flags':
Following consent, we will screen patients for ’red flags’ (such as new bleeding, rapid weight loss or vomiting that has not been previously reported to a health care practitioner) self-reported on a screening checklist. Note: The “red flags” criteria have been developed in consultation with 5 consultant gastroenterologists who are either co-applicants or part of our wider advisory group: they have each confirmed that they feel that participants who meet the criteria will be safe to enter an online self-management programme. If ineligible because of a red flag, a participant may be re-assessed if they contact the research team and report the information they have provided has changed such as the symptom has been adequately investigated or managed, in which case the participant can be included.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

680

Participant exclusion criteria

1. One or more “red flags” identified on pre-randomisation screening, (such as new bleeding, rapid weight loss or vomiting that has not been previously reported to a health care practitioner) self-reported on a screening checklist. Note: The “red flags” criteria have been developed in consultation with 5 consultant gastroenterologists who are either co-applicants or part of our wider advisory group: they have each confirmed that they feel that participants who meet the criteria will be safe to enter an online self-management programme. If ineligible because of a red flag, a participant may be re-assessed if they contact the research team and report the information they have provided has changed such as the symptom has been adequately investigated or managed, in which case the participant can be included.
2. Inability to give informed consent (for example, due to reduced mental capacity)
3. Insufficient command of English to understand study documents and procedures

Recruitment start date

01/10/2019

Recruitment end date

30/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London North West University Healthcare NHS Trust
Northwick Park Hospital Watford Road Harrow
Middlesex
HA1 3UJ
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Salford Royal Stott Lane Salford
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

London North West University Healthcare NHS Trust

Sponsor details

Research and Development
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
020 8864 3232
LNWH-tr.Research@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.lnwh.nhs.uk/research/

Funders

Funder type

Government

Funder name

Programme Grants for Applied Research

Alternative name(s)

NIHR Programme Grants for Applied Research, PGfAR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We will submit results for publication in multidisciplinary academic journals (such as Inflammatory Bowel Diseases and Journal of Crohn’s & Colitis) to disseminate to professional audiences. We will submit to key IBD conferences, including the UK British Society of Gastroenterology, the European Crohn’s & Colitis Organisation and the USA Digestive Diseases Week.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to risk of patient identification.

Intention to publish date

01/11/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/09/2019: Trial’s existence confirmed by London - Surrey Research Ethics Committee